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May 31, 2012

House Passes User Fee Bill

Less than a week after the Senate passed its version of a bill amending the user fee provisions of the Food, Drug and Cosmetic Act (FDCA) for funding FDA review of innovator and generic drugs, medical device and biosimilars (S. 3187; Food and Drug Administration Safety and Innovation Act), the House passed its own version of the bill (H.R. 5651; Food and Drug Administration Reform Act of 2012). The bill was passed by a vote of 387-5 (with 39 abstentions); the naysayers include Reps. Ron Paul (R-TX-14), Tom McClintock (R-CA-4), Justin Amash (R-MI-3), Raul Labrador (R-ID-1), and Maurice Hinchey (D-NY-22). Like the Senate bill, the House version reauthorizes prescription drug (PDUFA; Title I) and medical device (MDUFA; Title II) user fees, as well as establishing new user fees for generic drugs (GDUFA; Title III) and biosimilars (BsUFA; Title IV).

The bill is not yet ready for President Obama's signature, however; there are several differences between the Senate and House bills that have been conveniently compared in tabular form by the Congressional Research Service. There are no significant differences between the bills regarding the biosimilars provisions discussed in an earlier post regarding the Senate bill provisions (see "Senate Passes User Fee Bill"). Notable differences include no counterpart to Senator Coburn's amendment to the Senate bill (Section 723) requiring the Secretary to contract with a "private, independent" consulting firm to assess agency performance of its premarket review of drug applications. The House bill contains provisions not found in the Senate bill, for example that extend the time for agency approval after an ANDA is filed from 30 months to 45 months.

It is estimated that the bill could be ready for the President's signature by mid-summer.